- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01780805
Second Young Adult Naturalistic Alcohol Study (YANAS-2)
Second Young Adult Naturalistic Alcohol Study (YANAS-2)
This study involves completion of questionnaires, computer-based cognitive tasks and an alcohol drinking session. Participation in this study consists of an initial, in-person screening appointment, 4 brief daily appointments at the research office, an alcohol drinking session at a local bar and a follow-up appointment 1-3 days after the alcohol drinking session.
Participants who are found to be eligible in the screening phase will then complete a daily appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on which they will not attend an appointment). Each appointment will last 20 minutes, on average and consist of a questionnaire and computer-based cognitive task. On the day of the fourth appointment, participants will complete an alcohol drinking session. The alcohol drinking session begins at 4pm and lasts until at least midnight.
Participants in this study will be young adults between the ages of 21-25, who regularly drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two participants will complete this study.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Yale University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be between the ages of 21-25.
- Be able to read English and complete study evaluations.
- Drink alcohol on a regular basis
Exclusion Criteria:
No participant may:
- Be seeking treatment for alcohol or other addictive behaviors or have been in inpatient or intensive outpatient treatment within the past 12 months.
- Provide two positive breath alcohol concentration (BAC) readings (i.e., > 0.00%) at any of the following times: in-person screening, a pre-session screening, or at the outset of an alcohol self-administration session. After participants blow their first positive BAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BAC, they will be excluded from this study and offered referrals for alcohol treatment.
- Have positive urine screen results at the in-person screening or pre-session screening on the day of an alcohol self-administration session for opiates, cocaine, phencyclidine, amphetamines, methamphetamine, barbiturates, methadone or benzodiazepines.
- A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.
- Fail to perform at a normative level at screening on any of the four cognitive and psychomotor tasks administered in this study. Participants must perform within two standard deviations of the mean from the samples in relevant prior studies
- Perform computer tasks initially administered at baseline in either a random or inordinately slow fashion
- A body mass index lower than 18.5 or greater than 35.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Young adult alcohol drinkers
Young adults between the ages of 21-25 who regularly drink alcohol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak estimated blood alcohol concentration
Time Frame: During a 3-hour alcohol drinking period
|
During a 3-hour alcohol drinking period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of alcoholic drinks consumed
Time Frame: During a 3-hour alcohol drinking period
|
During a 3-hour alcohol drinking period
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported drinks per drinking day
Time Frame: 6- and 12-month follow-ups after alcohol drinking session
|
6- and 12-month follow-ups after alcohol drinking session
|
Self-reported frequency of heavy drinking days
Time Frame: 6- and 12-month follow-up after alcohol drinking session
|
6- and 12-month follow-up after alcohol drinking session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert F Leeman, Ph.D., Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1209010754
- R03AA022232 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Young Adult Alcohol Drinking
-
Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingBinge Drinking | Heavy Drinking | Young Adult | Heavy DrinkerUnited States
-
Yale UniversityTerminatedAlcohol Drinking | Drinking Behavior | Binge Drinking | Heavy Drinking | College Drinking | Alcohol Drinking in College | Young Adult | Heavy Drinker | Drunkenness | Drinking Excessive | Drinking Problem | Drink Too MuchUnited States
-
Wecare Probiotics Co., Ltd.Not yet recruitingAlcohol Drinking, Adult Disease
-
Wecare Probiotics Co., Ltd.Not yet recruitingAlcohol Drinking | Adult Disease
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Canadian Cancer Society (CCS)Recruiting
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
University of ValenciaCompleted
-
Boston University Charles River CampusRecruiting
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand